Oncology trials in China may see pilot program for 60-day IND decision

Investigational new drug applications for oncology in China may see a 60-day deadline for a thumbs up, or down, placing the country on a path already followed by Singapore, Taiwan and South Korea in Asia for quick early-stage decisions.

Industry sources said that in a meeting held by the China FDA's Center for Drug Evaluation this month, the agency told clinical researchers and company executives that a pilot plan is on the drawing board for oncology products because of growing interest and therapeutic need.

Earlier this month, China moved to spur drug approvals in a breakthrough that included accepting multi-region clinical trial processes as part of an effort to clear nearly 20,000 medicine approval requests pending and allowing more innovative therapies to reach the market

The moves, announced by the State Council, or cabinet, made it clear that simultaneous clinical trials of novel drugs and the data gathered from global trials would be accepted in the process of whether to approve innovative therapies.

In addition, the State Council said that overseas drugmakers can ask the CFDA to expedite reviews if a drug addresses unmet needs in areas like oncology, though the price cannot be more than in the drug's home market or countries similar to China.

For China-focused oncology firms such as BeiGene, which received China FDA approval for a clinical trial application on small-molecule candidate BGB-283, a second-generation BRAF inhibitor this month, or ZAI Lab, which in-licensed a novel multi-kinase inhibitor aimed at a non-small cell lung cancer target from Sanofi ($SNY) also in August--a 60-day decision window could be a spur for more such work.

As well, multinational firms may be more willing to look at China-specific early-stage work, though there is a wider expectation that the aim is for innovative local firms to benefit as national champions, an industry source said.

"The list of possible China focused partners grows by the day from Hutchison MediPharma to all of the CROs such as WuXi (PharmaTech)," said the industry source, adding that it is likely multinationals would look for partners.

The source noted that nearly three years ago Singapore and South Korea cut IND decision times to approve or deny an application for a clinical trial certificate within 30 working days or less for most drug trials in order to become hubs for early-stage work in Asia.

"I do not think the CFDA has the same goal in mind," the source said. "This is really a therapeutic need areas and if it goes well, the thinking is it may extend to other pressing therapeutic needs."

Currently, China requires clinical trial sponsors to wait anywhere from a year to two before the actual start of work and that may also act to keep local hospitals out of global trials as approval times are faster in the U.S. as well at around 30 days.

- here's the meeting notice (Chinese language)